Substance Abuse and Mental Health Services Administration and National
Institute on Alcohol Abuse and Alcoholism Feature VIVITROL in Recent
Publications
FRAZER, Pa. and CAMBRIDGE, Mass., May 15 /PRNewswire-FirstCall/ -- The
Substance Abuse and Mental Health Services Administration (SAMHSA), a
public health agency within the U.S. Department of Health and Human
Services, issued its quarterly Substance Abuse Treatment Advisory developed
for the education of healthcare professionals in the field of substance
abuse. The advisory features a comprehensive overview of VIVITROL(R)
(naltrexone for extended- release injectable suspension), the first and
only once-monthly injectable medication for the treatment of alcohol
dependence, which was approved by the FDA in April 2006.
This advisory follows the publication of an updated version of Helping
Patients Who Drink Too Much: A Clinician's Guide from the National
Institute on Alcohol Abuse and Alcoholism (NIAAA). The Guide was recently
updated to include information about VIVITROL as the most recently
FDA-approved medication for the treatment of alcohol dependence.
"We are pleased that these government organizations have formally
recognized VIVITROL, the first and only once-monthly injectable medication
for the treatment of alcohol dependence, as an important and effective
treatment option in their recent publications," said David Gastfriend, MD,
Vice President, Medical Affairs at Alkermes. "We encourage healthcare
providers, including addiction specialists and primary care doctors, to
utilize this valuable information as they evaluate and treat their patients
who struggle with the deadly disease of alcoholism."
ABOUT THE PUBLICATIONS
The Spring 2007 issue of the SAMHSA Substance Abuse Treatment Advisory
features information about VIVITROL including efficacy, safety and patient
adherence information. It also includes guidance for healthcare
professionals on administration of VIVITROL and tips on how to educate
patients about treatment with VIVITROL. To obtain a free copy of the
advisory entitled "Naltrexone for Extended-Release Injectable Suspension
Treatment of Alcohol Dependence" please visit:
http://www.kap.samhsa.gov/products/manuals/advisory/index.htm or call
1-800-729-6686.
The NIAAA publication Helping Patients Who Drink Too Much: A
Clinician's Guide was developed by the NIAAA with the guidance of
physicians, nurses, physician assistants and clinical researchers for a
wide audience, which includes mental health as well as primary care
practitioners, to educate them about how to effectively manage and treat
patients with alcoholism. The Guide now includes an updated medications
chart and information about each FDA- approved medication for the treatment
of alcohol dependence, including VIVITROL. The Guide is available on the
NIAAA website, http://www.niaaa.nih.gov/guide.
ABOUT VIVITROL
VIVITROL is a once-monthly, single dose 380 mg intramuscular gluteal
injection indicated for patients who are able to abstain from drinking
alcohol in an outpatient setting and who are not actively drinking prior to
treatment initiation. VIVITROL should be used as part of a comprehensive
management program that includes ongoing counseling or group therapy.
VIVITROL, a long-acting form of naltrexone, is effective and generally
well tolerated for the treatment of alcohol dependence. In clinical trials,
when used in combination with psychosocial support, VIVITROL was shown to
reduce the number of drinking days and heavy drinking days and to prolong
and maintain abstinence in patients who abstained from alcohol the week
prior to starting treatment.
The proprietary Medisorb(R) drug delivery technology utilized in
VIVITROL allows the medication to be gradually released into the body at a
controlled rate over a one-month time period, providing patients with
convenient monthly dosing, which alleviates the need for patients to make
daily medication decisions.
VIVITROL is non-addictive - patients did not develop a tolerance for or
dependence on VIVITROL. VIVITROL is non-aversive, meaning patients do not
become ill as a result of drinking alcohol while on VIVITROL.
VIVITROL should be administered by a healthcare provider. Ongoing
interactions with healthcare professionals strengthen the therapeutic
alliance and collaborative relationship healthcare professionals form with
patients, which is an important component in the recovery process.
VIVITROL works by binding to opioid receptors in the brain. Although
the mechanism responsible for reduction in alcohol consumption is not
entirely understood, preclinical data suggest that occupation of the opioid
receptors by VIVITROL may result in the blockade of the neurotransmitters
in the brain believed to be involved with the pleasurable and rewarding
effects of alcohol. This blockade may result in the reduction in alcohol
consumption observed in patients treated with VIVITROL.
For more information about VIVITROL, please visit
http://www.vivitrol.com or call 1-800-VIVITROL (1-800-848-4876).
Important safety information
Naltrexone has the capacity to cause hepatocellular injury when given
in excessive doses.
Naltrexone is contraindicated in acute hepatitis or liver failure, and
its use in patients with active liver disease must be carefully considered
in light of its hepatotoxic effects.
The margin of separation between the apparently safe dose of naltrexone
and the dose causing hepatic injury appears to be only five-fold or less.
VIVITROL does not appear to be a hepatotoxin at the recommended doses.
Patients should be warned of the risk of hepatic injury and advised to
seek medical attention if they experience symptoms of acute hepatitis. Use
of VIVITROL should be discontinued in the event of symptoms and/or signs of
acute hepatitis.
VIVITROL is contraindicated in patients receiving or dependent on
opioids, in acute opioid withdrawal, and in those who have failed the
naloxone challenge test or have a positive urine screen for opioids; and in
those with previous hypersensitivity to naltrexone, PLG,
carboxymethylcelluose, or any other components of the diluent.
Patients must be opioid free for a minimum of 7-10 days before
treatment. Attempts to overcome opioid blockade due to VIVITROL may result
in fatal overdose. In prior opioid users, use of opioids after
discontinuing VIVITROL may result in fatal overdose because patients may be
more sensitive to lower doses of opioids. Patients requiring reversal of
the VIVITROL blockade for pain management should be monitored by
appropriately trained personnel in a setting equipped for cardiopulmonary
resuscitation.
Consider the diagnosis of eosinophilic pneumonia if patients develop
progressive dyspnea and hypoxemia. Injection site reactions not improving
may require prompt medical attention. Alcohol-dependent patients, including
those taking VIVITROL, should be monitored for the development of
depression or suicidal thinking. Caution is recommended in administering
VIVITROL to patients with moderate to severe renal impairment.
The most common adverse events associated with VIVITROL in clinical
trials were nausea, vomiting, headache, dizziness, asthenic conditions and
injection site reactions. For full prescribing information, please visit
http://www.vivitrol.com or call 1-800-896-5855.
About Cephalon and Alkermes
Through their corporate joint collaboration, Cephalon, Inc. (Nasdaq:
CEPH) an international biopharmaceutical company, and Alkermes, Inc.
(Nasdaq: ALKS), a biotechnology company, have made available VIVITROL(R)
the most recently FDA-approved medication for the treatment of alcohol
dependence. VIVITROL was developed and is manufactured by Alkermes and is
marketed by Cephalon. For more information about Cephalon and Alkermes.
please visit: http://www.cephalon.com or http://www.alkermes.com.
Certain statements set forth above may constitute forward-looking
statements within the meaning of the Private Securities Litigation Reform
Act of 1995, including, but not limited to, the utilization of the SAMHSA
and NIAAA publications by healthcare providers. Although the companies
believe that such statements are based on reasonable assumptions within the
bounds of its knowledge of its business and operations, the forward-looking
statements are neither promises nor guarantees and the companies'
businesses are subject to significant risk and uncertainties and there can
be no assurance that its actual results will not differ materially from its
expectations.
These risks and uncertainties include whether healthcare providers,
including addiction specialists and primary care doctors, utilize the
information found in the SAMHSA and NIAAA publications. For further
information with respect to factors that could cause the companies' actual
results to differ from expectations, reference is made to the respective
reports filed by each company with the Securities and Exchange Commission
under the Securities Exchange Act of 1934, as amended. The forward-looking
statements made in this release are made only as of the date hereof and
each of Cephalon and Alkermes disclaim any intention or responsibility for
updating such statements, except as may be required by law.
VIVITROL(R) is a registered trademark of Cephalon, Inc.
Medisorb(R) is a registered trademark of Alkermes, Inc.
SOURCE Cephalon, Inc.; Alkermes, Inc.
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Related links:
http://www.cephalon.com
http://www.vivitrol.com http://www.alkermes.com
http://www.niaaa.nih.gov/guide
http://www.prnewswire.com/comp/134563.html/
CONTACT:
Corporate-Media Contact: Karen Boyce McCollum
of Cephalon, Inc., +1-610-883-5771, kboyce@cephalon.com; or
Corporate Contact: Rebecca Peterson of Alkermes, Inc.,
+1-617-583-6378, rebecca.peterson@alkermes.com
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